Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis

Last updated: May 12, 2025
Sponsor: Science Valley Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Eczema (Atopic Dermatitis)

Treatment

cold cream

short-pulse ND: YAG 1064 laser

ultra-short-pulse ND: YAG 1064 laser

Clinical Study ID

NCT06980961
SUPERSTAR trial
  • All Genders

Study Summary

This study tests two types of lasers (ND YAG 1064 short and ultra-short pulses) to treat hyperchromic skin lesions secondary to venous hypertension (stasis dermatitis)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women or men aged 18 to 89 years with stasis dermatitis secondary to venoushypertension

  2. Agreement with the terms of the survey and signing of the informed consent form

  3. Availability to make the necessary appointments for treatment and follow-up

  4. Provide consent to avoid pregnancy during treatment

  5. Have primary venous hypertension already treated (treatment of varicose veins of thelower limbs) by any of the available techniques

Exclusion

Exclusion Criteria:

  1. Men and women with CEAP 2 to 6, low mobility, no stasis dermatitis.

  2. Peripheral arterial disease.

  3. History of known allergy to the drugs used in this study

  4. Presence of other types of dermatitis in the lower extremities, such as allergicstasis eczema.

  5. Presence of comorbidities (such as diabetes mellitus, heart failure, respiratoryfailure, hypertension, hypothyroidism, or hyperthyroidism), pregnancy,breastfeeding, pulmonary hypertension, deep vein thrombosis (DVT), family history ofDVT, known hypercoagulable states or thrombophilia, asthma, and migraine.

  6. Anyone who does not agree with any of the search terms.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: cold cream
Phase:
Study Start date:
May 20, 2025
Estimated Completion Date:
December 01, 2026

Study Description

Background: Stasis dermatitis with hyperpigmented skin lesions is a serious health problem for patients with chronic venous hypertension. Although no randomized studies have evaluated lasers for this treatment, lasers can be an attractive option.

Methods: This prospective, randomized, 3-arm, open-label, vehicle-controlled study will enroll patients scheduled to undergo treatment for stasis dermatitis with hyperpigmented skin lesions. Patients will be allocated to either Nd: YAG 1064 nm short pulse laser-nanoseconds (group 1), or Nd: YAG 1064 nm ultra-short-pulse laser-picoseconds (group 2), or cold cream vehicle control (group 3). All treatments are scheduled for 6 visits with pre-defined dates, with a final follow-up visit at intervals of 28 to 35 days. Primary outcomes include colorimetry analysis, secondary outcomes pre- and post-photographic analysis, and DLQI quality-of-life assessment.

Conclusions: The results of this trial will provide high-quality evidence to guide clinical practice on optimal management of hyperpigmented skin lesions secondary to stasis dermatitis.

Connect with a study center

  • Clinica Ramacciotti

    Santo Andre, SP 09090401
    Brazil

    Active - Recruiting

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